This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Modifications to in-process acceptance criteria and final in-process acceptance criteria
| Device | ORSIRO Sirolimus Eluting Coronary Stent System |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Biotronik, Inc |
| Date Received | 2021-01-19 |
| Decision Date | 2021-02-17 |
| PMA | P170030 |
| Supplement | S014 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Biotronik, Inc 6024 Jean Road lake Oswego, OR 97035 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170030 | Original Filing | |
| S014 | 2021-01-19 | 30-day Notice |
| S013 | 2020-10-16 | 30-day Notice |
| S012 | 2020-10-16 | 30-day Notice |
| S011 | 2020-10-02 | Normal 180 Day Track No User Fee |
| S010 | 2020-09-21 | 30-day Notice |
| S009 | ||
| S008 | 2020-07-22 | 30-day Notice |
| S007 | ||
| S006 | 2020-06-02 | 30-day Notice |
| S005 | 2019-11-04 | 30-day Notice |
| S004 | 2019-09-27 | 30-day Notice |
| S003 | 2019-04-17 | Normal 180 Day Track No User Fee |
| S002 | ||
| S001 |